Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defects

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOctober 6 University

About this trial

This study aims to clinically and radiographically evaluate the adjunctive effect of injectable platelet-rich fibrin (i-PRF) used in combination with a minimally invasive non-surgical technique for the regenerative treatment of intrabony periodontal defects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients of both genders >18 years old, medically free of systemic diseases affecting periodontal regeneration.

Diagnosis of 'periodontitis' stage III (grades B or C).

Single-rooted and multi-rooted vital teeth in either the maxilla or the mandible.

Presence of comparable bilateral two- or three-walled intrabony defects [probing pocket depth (PPD), > 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph] not in a furcation-involved tooth.

Disqualifiers

Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.

Pregnant and lactating women

Current use of any form of tobacco.

Non-surgical periodontal treatment in the past 6 months, or surgical periodontal treatment in the past 12 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minimally invasive non-Surgical technique

    Procedure/Surgery

    Patients will receive minimally invasive non-Surgical technique (MINST) alone

  • Minimally invasive non-Surgical technique + platelet-rich fibrin

    Procedure/Surgery

    Patients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group 1 (control group)Active comparator 1 intervention
Group B: Group 2 (Test group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Presence of comparable bilateral-walled intrabony defects

Assessment of intrabony defect fill radiographically will be measured using the standardized paralleling technique. Presence of comparable bilateral-walled intrabony defects (PPD, \> 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph) not in a furcation-involved tooth.

Time frame
6 months postoperatively

Secondary outcomes

1

Clinical attachment level

Clinical attachment level (CAL) will be measured in millimeters from the cemento-enamel junction (CEJ) to the base of the periodontal sulcus at 6 sites per tooth

Time frame
6 months postoperatively
2

Interproximal probing depth

Probing depth (PD) will be measured in millimeters from the gingival margin to the base of the periodontal sulcus at 6 sites per tooth

Time frame
6 months postoperatively
3

Gingival margin

Gingival margin will be measured from the cemento-enamel junction (CEJ).

Time frame
6 months postoperatively
4

Bleeding on probing

Bleeding on Probing (BoP) will be measured using papillary bleeding index that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus

Time frame
6 months postoperatively

Other outcomes

Sponsors and contacts

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